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Breast Cancer clinical trials

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NCT ID: NCT06246968 Recruiting - Breast Cancer Clinical Trials

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Start date: January 29, 2024
Phase: Phase 1
Study type: Interventional

Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.

NCT ID: NCT06240195 Recruiting - Breast Cancer Clinical Trials

Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in the Treatment of Patients With Triple-negative Breast Cancer in the Metastatic Phase: Prospective Multicenter Real-world Study

BIO-PROSA
Start date: January 17, 2023
Phase:
Study type: Observational

Observational, prospective, multicenter study. Collection of data relating to the effectiveness of sacituzumab govitecan SG, in a real-world context and planned research of predictive biomarkers of efficacy/tolerability carried out on multiple platforms at the center coordinator.

NCT ID: NCT06239467 Recruiting - Breast Cancer Clinical Trials

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

PIKture-01
Start date: March 1, 2024
Phase: Phase 1
Study type: Interventional

OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with fulvestrant or trastuzumab. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with standard dose fulvestrant (Part B) or standard dose trastuzumab (Part C). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.

NCT ID: NCT06239194 Recruiting - Breast Cancer Clinical Trials

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Start date: June 12, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

NCT ID: NCT06236373 Recruiting - Breast Cancer Clinical Trials

The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia

Survivorship
Start date: April 20, 2023
Phase:
Study type: Observational

This qualitative study seeks to explore the unmet needs of individuals who have recently undergone a cancer diagnosis and completed the acute phase of treatment. The primary objective is to utilize the experiences of patients, caregivers, and stakeholders to enhance the aftercare provided to cancer survivors. By delving into patient perceptions regarding unmet needs in cancer aftercare, the study aims to identify areas for redesigning and improving services to minimize these needs and ultimately enhance patient outcomes. Importantly, the investigation incorporates insights from patients, their caregivers, and stakeholders. The research will employ qualitative methods, specifically focus groups and interviews, to gather comprehensive perspectives from individuals in the Ausl IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. Including patients with diverse cancer types is crucial for capturing a broad spectrum of experiences. During data collection, both focus group discussions and interviews will be recorded in audio format and transcribed verbatim. This meticulous approach ensures an accurate representation of participants' voices and experiences. The subsequent analysis will employ a combination of framework and thematic analysis to extract meaningful insights and synthesize the data effectively. The study's ultimate goal is to leverage the findings to optimize aftercare services for cancer survivors within the local context of Ausl IRCCS Reggio Emilia. By incorporating the perspectives of patients, caregivers, and stakeholders, the research aims to contribute valuable insights that can inform the redesign and improvement of aftercare services, ultimately benefitting cancer survivors in the region.

NCT ID: NCT06229392 Recruiting - Breast Cancer Clinical Trials

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

Start date: February 28, 2024
Phase: Phase 1
Study type: Interventional

This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.

NCT ID: NCT06228768 Recruiting - Breast Cancer Clinical Trials

Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer

Start date: March 6, 2024
Phase: N/A
Study type: Interventional

This is a randomized, double-blinded trial of self-acupressure to examine the effect of treatment on aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in postmenopausal women with breast cancer. Acupressure is similar to acupuncture, but uses pressure rather than needles to stimulate specific points on the body. Acupressure involves applying mild to moderate physical pressure using your fingers, or an assistive device, to these points to try to bring about a physiological change in your body, in this case relief from joint pain and stiffness. The investigators will also examine effects of acupressure on other symptoms that commonly develop in AI-treated patients. In addition, changes in stool microbiome with acupressure treatment will be examined in an exploratory way to obtain preliminary information about the effect of acupressure on the gut microbiome in this condition.

NCT ID: NCT06227728 Recruiting - Breast Cancer Clinical Trials

Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.

Start date: March 22, 2024
Phase:
Study type: Observational [Patient Registry]

This is an observational clinical trial, aiming to investigate whether the ctDNA dynamics could predict early response to ICIs in patients with advanced-stage cancer. Moreover, conventional tumor markers PD-L1, TMB and MSI are to be investigated for their combined prognostic values in ICI treatment.

NCT ID: NCT06227338 Recruiting - Breast Cancer Clinical Trials

ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study

BREASTIFLU-1
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment. Two preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm. In the first time frame (intraoperative arms), the dose of, respectively 0.125 mg/kg and 0.25 mg/kg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups. In the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.

NCT ID: NCT06227117 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer

Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer